Posted to MedZilla on 3/30/2017


Takeda Pharmaceuticals

US-MA, Associate Scientific Director Pharmaceutical Sciences Program Management 1602640-MZ


 
 

OBJECTIVES:

  • Independently leads development of PS strategy and plans for multiple programs
  • Projects (and is recognized for) expertise in cross functional/divisional team leadership and communication
  • Leads and influences functional/divisional strategy and initiatives
  • Clearly communicates portfolio development to stakeholders.

ACCOUNTABILITIES:

Program Management:
  • Leads/represents PS on multiple cross-divisional governance and development teams while providing strategy and accountability for PS deliverables.
  • Provides strategic scientific leadership and program management for multiple global PS development teams
  • Identifies and communicates project or program risks and provides risk response strategies in a timely manner to appropriate stakeholders and PS management
  • Lead/participate as functional expert in divisional and cross-divisional initiatives
  • Leads the preparation of the PS sections of global regulatory submissions (e.g. CTAs and commercial applications) and PS responses to regulatory agencies; represents PS at meetings with regulatory agencies, as necessary.
  • Manages PS development activities performed by external partners and companies to ensure project deliverables are being met; reviews contracts and invoices as necessary.
Technical Acumen:
  • Provides scientific leadership and innovation in pharmaceutical research and development.
  • Mentors other members to develop their capabilities to lead and advance their individual skills of pharmaceutical product development and program management
  • Identifies, evaluates, develops, recommends and/or negotiates novel solutions to meet critical project needs.
  • Applies scientific knowledge and principles to solve project problems and significantly influence the direction of projects/programs.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / Experience
BS + 16 years; MS + 12 years; Pharma D + 11 years; PhD + 10 years
Technical Skills/Competencies:
  • Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions.
  • Experience must be in a scientific discipline with expert knowledge of pharmaceutical development, including an understanding of current laboratory techniques, instrumentation, problem solving techniques, process engineering and manufacturing development, and statistics used in experimental work.
  • Must demonstrate knowledge of several allied fields such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. Fundamental understanding in DMPK, Pharmacology and Toxicology.
  • Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies.
  • Must have experience in global regulatory submission requirements and processes.
Program Management Skills/Competencies
Proficient in the application of project management knowledge, skills, tools (e.g. Microsoft Project), and techniques for complex multidisciplinary programs and initiatives.
  • Leadership - develops and uses knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program and cross-divisional goals and objectives; adapts well to varied team dynamics and manages others team members in a respectful manner.
  • Risk Management ability to identify/mitigate technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies. Ability to identify gaps in PS technology/trends and influence change/improvements to affected areas/processes.
  • Communication ability to expresses one s self clearly and concisely to key stakeholders and functional management; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience. Can represent PS viewpoint at divisional level.
  • Resource Management Ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital).

LICENSES/CERTIFICATIONS:

  • PMP certification is preferred
*LI-JW1-USA
we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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